A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants

Phase 1

Completed

• Conditions: Migraine
• Interventions: Drug: Lu AG09222; Drug: Placebo

• Registration Number: NCT05304910
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• The participant is Japanese, defined as having 4 Japanese grandparents, or the participant is Caucasian, or the participant is Chinese, defined as having 4 Chinese grandparents.
• The participant has a body mass index (BMI) ≥18 and ≤28 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Baseline Visit.

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Exclusion Criteria

• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
• The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP).
• The participant has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) <6 months prior to the first dose of IMP.
• The participant has previously been dosed with Lu AG09222.
• The participant has a history of severe drug allergy or hypersensitivity.

Other inclusion and exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AG09222 Low Dose	Lu AG09222	Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1.
Lu AG09222 High Dose	Lu AG09222	Participants will receive a single dose of Lu AG09222 by SC injection on Day 1.
Placebo	Placebo	Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)	Day 1 (predose) to Day 84
Maximum Observed Concentration (Cmax) of Lu AG09222	Day 1 (predose) to Day 84
Apparent Elimination Half-Life (t½) of Lu AG09222	Day 1 (predose) to Day 84
Time to Maximum Observed Concentration (tmax)	Day 1 (predose) to Day 84
Apparent Total Clearance (CL/F)	Day 1 (predose) to Day 84
Apparent Volume of Distribution (Vz/F)	Day 1 (predose) to Day 84

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA])	Day 1 (predose) to Day 84
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)	Day 1 (predose) to Day 84

Trial Locations

Locations (1)

PAREXEL International; 🇺🇸 Glendale, California, United States